On October 22, 2020 Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, reported its business update and interim report for January – September, 2020 (Press release, Hansa Biopharma, OCT 22, 2020, View Source [SID1234568888]).

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Highlights for the third quarter 2020

The EU Commission granted conditional approval for Idefirix (imlifidase) in highly sensitized kidney transplant patients in the European Union. Idefirix is the Company’s first approved drug and will transform Hansa Biopharma into a commercial stage biopharmaceutical company.
Entered exclusive agreement with Sarepta Therapeutics to develop and promote imlifidase as pre-treatment ahead of gene therapy in select indications. The agreement with Sarepta includes an upfront payment and will potentially generate milestone payments to Hansa totaling up to USD 397.5m plus royalties on imlifidase enabled gene therapy sales. All imlifidase sales will be booked by Hansa.
Anti-GBM: Reported positive high-level data from investigator-initiated phase 2 trial with imlifidase to treat anti-GBM disease with two-thirds of patients achieving dialysis independence six months after treatment. The positive data marks an important milestone for the Company’s expansion of imlifidase outside transplantation.
US trial in kidney transplantation: Recruitment of first patient expected in H1 2021, given the continued impact of the COVID-19 pandemic in the US and the timeline to finalize the study protocol. Potential BLA submission is expected by 2023 under the accelerated approval path.
Pipeline: Enrollment in both phase 2 studies in GBS and AMR have been temporarily halted for the past months due to the COVID-19 pandemic. Reinitiation of enrollment expected in Q4 2020 under a risk-based site-by-site approach. Completion of enrollment in both studies is expected in the second half of 2021.
Hansa Biopharma AB certified as a Great Place to Work following the results of a company-wide employee survey and a review of policies.
SEK 1.1bn (USD 121m) raised in a directed share issue of 4.4 million ordinary shares. The share issue was multiple times oversubscribed due to high demand from US, European and Swedish institutional investors. The capital raised will help finance the Company’s R&D pipeline as well as fund the launch and commercialization of imlifidase in kidney transplantation.
Max Sakajja, VP Corporate Development, appointed to a new role as VP International Markets to prepare Hansa Biopharma’s expansion strategy outside the EU. The role reports into the CCO and is part of Hansa’s broader leadership team.
Investments in R&D and SG&A increased in the third quarter to SEK 71m (Q3’19: SEK 47m) and SEK 52m (Q3’19: SEK 46m), respectively. Cash position was SEK 1,476m at the end of September 2020. Cash flow from operating activities for the third quarter ended at SEK 5m (Q3’19: SEK -80m).
Søren Tulstrup, President and CEO of Hansa Biopharma, comments

"Hansa Biopharma’s evolution into a fully integrated biopharmaceutical company took a major step forward in the third quarter following the conditional approval of Idefirix (imlifidase) by the European Commission for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor.

The European approval serves as a validation of the potential of our proprietary drug development platform and will transistion Hansa Biopharma into the next phase as a commercial stage biopharmaceutical company.

We are also excited about the progress of our efforts beyond transplantation. In July we announced the achievement of another landmark milestone with the exclusive agreement with Sarepta Therapeutics to develop and promote imlifidase as a potential pre-treatment prior to the administration of gene therapy. The agreement with Sarepta is exclusive for the use in Duchenne and and Limb-Girdle indications and serves as a validation of our enzyme technology as we expand beyond transplantation.

Late Septermber we also announced positive high-level data from the investigator-initiated phase 2 trial with imlifidase to treat anti-GBM disease. Data from the trial shows that imlifidase leads to rapid clearance of anti-GBM antibodies, with two-thirds of patients achieving dialysis independence six months after treatment. We are very encouraged by the positive outcome as anti-GBM is the first IgG-mediated disease outside transplantation, where imlifidase has been shown to stop an immunologic attack.

Our strong progress across our platform of immunomodulatory enzymes has also been recognized by our investors, as our investor base has continued to expand in Sweden and internationally. End of September, the number of shareholders has increased to more than 18,000 investors, with 45% of the shares now owned by international investors and institutions. We see this as a testimony to our recent progress and a strong and growing international interest in Hansa Biopharma.

While an exciting and transformative year has impacted us in a postive way, we are still seeing negative effects due to the widespread impact from the COVID-19 pandemic. Enrollment in the phase 2 studies in GBS and AMR has been temporarily halted for the past months, and we expect to reinitiate enrollment of these studies in the fourth quarter 2020 under a risk-based, site-by-site approach.

In the US, the proposed study protocol for a randomised controlled trial (RCT) targeting highly-sensitized kidney patients was submitted to the FDA in June, 2020. Discussions are currently ongoing with the FDA and, once the final protocol has been agreed upon, we will proceed to set up centers in the US and start to enroll patients. Given the continued impact of the COVID-19 pandemic and the timeline for finalization of the study protocol, we expect recruitment of the first patient to be in the first half of 2021 with a potential BLA submission in 2023.

Lastly, I also want to highlight that Hansa Biopharma AB recently got certified as a Great Place to Work. This certification reflects our efforts to build a strong organization through attracting, developing and retaining the very best talent in the industry as we continue our growth trajectory and development into a fully integrated biopharmaceutical company.

I look forward to keeping you updated on the progress of our journey."

Upcoming milestones and news flow

Q4 2020 Kidney transplantation EU: Commercial launch

H1 2021 Kidney transplantation US: First patient dosed / RCT

H1 2021 NiceR: Completion of GMP process; initiate IND-enabling tox studies

H2 2021 AMR Phase 2 study: Complete enrollment

H2 2021 GBS Phase 2 study: Complete enrollment

2022 Kidney transplantation US: Complete enrollment / RCT

H2 2022 AMR Phase 2 study: Data read out

H2 2022 GBS Phase 2 study: Data read out

2023 Kidney transplantation US: 12 months follow-up on eGFR completed / RCT

2023 Kidney transplantation US: BLA submission

Capital Markets Day

Hansa Biopharma to host Capital Markets Day on Thursday October 29, 2020 in Copenhagen

The CMD event will be focused around Hansa Biopharma’s transformation into a fully integrated and commercial stage biopharmaceutical company and will highlight the potential of the Company’s unique antibody-cleaving enzyme platform beyond transplantation in areas such as autoimmunity and gene therapy.

The event will feature both senior management and external guest speakers. The event will be livestreamed and available for all viewers on our web at View Source

If you wish to participate in the CMD virtually, kindly sign up using the following link View Source

No conference call scheduled on Oct 22, 2020

Since Hansa Biopharma will host its Capital Markets Day a week later than the Q3’2020 report it has been decided to incoporate relevant elements and updates from the third quarter into the CMD program and presentations rather than hosting a seperate Q3 conference call. There will be opportunites to ask questions during the Capital Markets Day.

On October 22, 2020 Alligator Bioscience reported that (Press release, Alligator Bioscience, OCT 22, 2020, View Source [SID1234568887])

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Encouraging clinical safety data for ATOR-1017

The Phase I study with ATOR-1017 has progressed exceptionally well and in August we presented interim data that showed a good safety profile at clinically relevant dose levels. The dose evaluation will continue with yet higher doses and we expect to present safety and potentially efficacy data from the entire study in the spring of 2021. At the same time, we have shown strong Proof of Mechanism data for mitazalimab, while the ATOR-1015 program reported side effects at high dose levels.The nature of the reactions have lead to a need to re-design the planned clinical trial in malignant melanoma and to perform additional preclinical investigations. We will now focus our clinical investments to ATOR-1017 and mitazalimab. Both programs have first-in-class potential, and will move into clinical Phase II during 2021", commented CEO Per Norlén.

SIGNIFICANT EVENTS JULY – SEPTEMBER

Mitazalimab:

Positive biomarker data demonstrating Proof of Mechanism in clinical Phase I study performed by Janssen.
Clinical development program defined. The CTA for the upcoming Phase II study in pancreatic cancer is scheduled to be submitted in December 2020.
ATOR-1015:

Revised plan due to further evaluation of doses and adverse reactions, leading to delay of Phase Ib.
US composition of matter patent granted.
ATOR-1017:

Encouraging emerging safety data at clinically relevant dose levels in the ongoing Phase I study.
Preclinical:

Neo-X-Prime: New unique drug concept for tumorspecific treatment launched at 11th World Bispecific Summit.
Other:

Gayle Mills appointed Chief Business Officer.
SIGNIFICANT EVENTS AFTER THE END OF THE PERIOD

Clinical focus on ATOR-1017 and mitazalimab:

Preparations to bring ATOR-1017 and mitazalimab to Phase II efficacy studies in 2021.
ATOR-1015: A partner will be sought for further clinical studies.
FINANCIAL SUMMARY

July-September 2020

Net sales, SEK 0.0 million (4.3).
Operating result, SEK -30.6 million (-58.5).
Result for the period, SEK -30.8 million (-56.6).
Earnings per share before and after dilution, SEK -0.43 (-0.79).
Cash flow for the period, SEK -32.7 million (-47.3).
Cash and cash equivalents, incl. interest-bearing securities, SEK 137.0 million (302.2)
January-September 2020

Net sales, SEK 4.4 million (4.4).
Operating result, SEK -110.2 million (-155.2).
Result for the period, SEK -108.8 million (-150.3).
Earnings per share before and after dilution, SEK-1.52 (-2.11).
Cash flow for the period, SEK 42.6 million (-27.8).
During the first quarter, the holdings in corporate bonds and interest funds were divested, which had a positive effect on cash flow.

Read the complete report in the pdf below.

Alligator will host a conference call today at 2:00 p.m. CEST for investors, analysts and media, where CEO Per Norlén will present and comment on the Q3 interim report and the focus of the clinical operations. The conference will be held in English. All necessary information to listen-in and ask questions are available on the following link: View Source

On October 22, 2020 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the third-quarter 2020 and updated full-year 2020 financial guidance (Press release, West Pharmaceutical Services, OCT 22, 2020, View Source [SID1234568886]).

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Third-Quarter 2020 Summary (comparisons to prior-year period)

Net sales of $548.0 million grew 20.1%; organic sales growth was 18.2%.
Reported-diluted EPS of $1.09 increased 45%.
Adjusted-diluted EPS of $1.15 increased 46%.
Company is raising full-year 2020 net sales guidance to a new range of $2.10 billion and $2.11 billion.
Company is raising full-year 2020 adjusted-diluted EPS guidance to a new range of $4.50 and $4.55.
"Adjusted-diluted EPS" and "organic sales growth" are Non-U.S. GAAP measurements. See discussion under the heading "Non-U.S. GAAP Financial Measures" in this release.

"Third-quarter results were robust across the entire business, led by High-Value Products (HVP) and Biologics. Additionally, we benefited from incremental sales related to the COVID-19 pandemic including components used with treatments and supporting therapies as well as potential vaccines currently in clinical trials," said Eric M. Green, President and Chief Executive Officer. "I am proud of our team members for their relentless passion and sense of urgency to help our customers and the patients we jointly serve. Continued excellence in executing our market-led strategy and our global operations position us well for the remainder of the year and into 2021."

Proprietary Products Segment
Net sales grew by 22.1% to $421.5 million. Organic sales growth was 20.3%, with currency translation increasing sales growth by 180 basis points. HVP components represented over 65% of segment sales and generated double-digit organic sales growth.

Our Biologics market unit had strong double-digit organic sales growth, led by Flurotec, Daikyo and NovaPure film-coated components, as well as Westar and Envision components. Our Generics market unit posted high single-digit organic sales growth, and our Pharma market unit grew organic sales by mid-single digits. Both Generics and Pharma market units were led by sales of film-coated and Westar components.

Contract-Manufactured Products Segment
Net sales grew by 14.0% to $126.6 million. Organic sales growth was 11.7% with currency translation increasing sales growth by 230 basis points. Segment performance was led by strong sales of healthcare-related injection and diagnostic devices.

Financial Highlights (first nine months of 2020)
Operating cash flow was $323.8 million, an increase of 24.2%. Capital expenditures were $116.7 million. Free cash flow (operating cash flow minus capital expenditures) was $207.1 million, an increase of 20.4%.

Full-Year 2020 Financial Guidance
Full-year 2020 net sales guidance is expected to be in a range of $2.10 billion and $2.11 billion, compared to a prior range of $2.035 billion and $2.055 billion.

Organic sales growth is expected to be approximately 14% to 15%, compared to a prior guidance of 12%.
Net sales guidance includes an estimated full-year headwind of $4 million for the full-year 2020 based on current foreign exchange rates, compared to prior guidance of a headwind of $26 million.
Full-year 2020 adjusted-diluted EPS is expected to be in a range of $4.50 and $4.55, compared to a prior range of $4.15 and $4.25.
Full-year adjusted-diluted EPS guidance includes an estimated headwind of approximately $0.02 based on current foreign currency exchange rates, compared to prior guidance of a headwind of $0.07.
The revised guidance includes an $0.18 EPS impact from tax benefits from stock-based compensation in the first nine months of 2020.
For the remainder of the year, our EPS guidance range assumes a tax rate of 24% and does not include potential tax benefits from stock-based compensation. Any tax benefits associated with stock-based compensation beyond those recorded in the first nine months of 2020 would provide a positive adjustment to our full-year EPS guidance.
Third-Quarter 2020 Conference Call
The Company will host a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time today. To participate on the call please dial 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is 7564183.

A live broadcast of the conference call will be available at the Company’s website, www.westpharma.com, in the "Investors" section. Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

An online archive of the broadcast will be available at the website three hours after the live call and will be available through Thursday, October 29, 2020, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International) and entering conference ID 7564183.

On October 22, 2020 Danaher Corporation (NYSE: DHR) (the "Company") reported results for the quarter ended October 2, 2020 (Press release, Danaher, OCT 22, 2020, View Source [SID1234568885]). All results in this release reflect only continuing operations unless otherwise noted.

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For the third quarter 2020, net earnings were $883.5 million, or $1.16 per diluted common share which represents a 38.0% year-over-year increase from the comparable 2019 period.

Non-GAAP adjusted diluted net earnings per common share were $1.72 which represents a 62.0% increase over the comparable 2019 period. Revenues increased 34.5% year-over-year to $5.9 billion, with 14.0% non-GAAP core revenue growth including Cytiva.

Operating cash flow for the third quarter 2020 was $1.7 billion, representing a 93.0% increase year-over-year, and non-GAAP free cash flow was $1.5 billion, representing a 110.0% increase year-over-year.

For the fourth quarter 2020 the Company anticipates that non-GAAP core revenue growth including Cytiva will be in the low-double digit range.

Rainer M. Blair, President and Chief Executive Officer, stated, "We delivered outstanding third quarter results, achieving double-digit revenue growth, over 60% adjusted EPS growth, and we more than doubled our free cash flow year-over-year. Since the onset of the COVID-19 pandemic, our team has turned unprecedented challenges into impactful opportunities to support our customers and the global community, and we’re proud to play a pivotal role in tackling COVID-19 head-on."

Blair continued, "Our performance is a testament to our associates’ dedication, as they stay focused on executing for our customers during the pandemic. With the Danaher Business System as our driving force and the powerful combination of our innovative team, strong portfolio of businesses, and solid balance sheet, we believe Danaher will continue to outperform well into the future."

Danaher will discuss its results during its quarterly investor conference call on October 22, 2020 starting at 8:00 a.m. ET. The call and an accompanying slide presentation will be webcast on the "Investors" section of Danaher’s website, www.danaher.com, under the subheading "Events & Presentations." A replay of the webcast will be available in the same section of Danaher’s website shortly after the conclusion of the presentation and will remain available until the next quarterly earnings call.

The conference call can be accessed by dialing 866-503-8675 within the U.S. or by dialing +1 786-815-8792 outside the U.S. a few minutes before the 8:00 a.m. ET start and telling the operator that you are dialing in for Danaher’s earnings conference call (access code 6799891). A replay of the conference call will be available shortly after the conclusion of the call and until November 5, 2020. You can access the replay dial-in information on the "Investors" section of Danaher’s website under the subheading "Events & Presentations." In addition, presentation materials relating to Danaher’s results have been posted to the "Investors" section of Danaher’s website under the subheading "Quarterly Earnings."

On October 22, 2020 Theravance Biopharma, Inc. (NASDAQ: TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, reported that it will report its third quarter 2020 financial results and provide a business update after market close on Thursday, November 5, 2020 (Press release, Theravance, OCT 22, 2020, View Source [SID1234568884]). An accompanying conference call and simultaneous webcast will be hosted at 5:00 p.m. ET (2:00 p.m. PT/10:00 p.m. GMT) that day.

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Conference Call Information

To participate in the live call by telephone, please dial (855) 296-9648 from the US or (920) 663-6266 for international callers, using the confirmation code 1269525. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma’s website at www.theravance.com, under the Investor Relations section, Presentations and Events.

A replay of the conference call will be available on Theravance Biopharma’s website for 30 days through December 5, 2020. An audio replay will also be available through 8:00 p.m. ET on November 12, 2020 by dialing (855) 859-2056 from the US, or (404) 537-3406 for international callers, and then entering confirmation code 1269525.